Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia

Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.

Study Overview

• Status: Completed
• Conditions: MASTECTOMY
• Intervention / Treatment: Procedure: Erector spina plain block for mastectomy analgesia; Procedure: Deep serratus anterior plane block

Detailed Description

Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.

Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, P.o.Box 7805, 11472
    • King Saud University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery

Exclusion Criteria:

• Patients refusal
• History of amide local anesthetics allergy
• Alcohol or drug abuse
• Chronic opioid intake
• Language barriers
• Patient with psychiatric disorders
• Contraindications for regional anesthesia
• BMI > 40 Kg/m2
• Obstructive sleep apnea that preclude PCA opioids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESPB GROUP; Erector spina plane block group	Procedure: Erector spina plain block for mastectomy analgesia; After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, An erector Spina plain block is performed with inserting block needle (Pajunk, Geisingen, Germany) in-plane under ultrasound control until needle tip hits the transverse process, a volume of 0.3 ml/kg of bupivacaine 0.25% (Marcaine, Astra Zeneca Pharmaceuticals) is injected. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia (PCA) for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10) and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to post-anesthesia care unit PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented
Active Comparator: SAPB group; Deep Serratus anterior plane block group	Procedure: Deep serratus anterior plane block; After giving general anesthesia, the patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. A block needle is introduced in-plane, targeting the plane deep to the serratus anterior muscle, and a bolus of 0.3 ml/kg bupivacaine 0.25% is injected through ultrasound guidance. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia PCA for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10), and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid consumption in the first 24 hours.	Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)	0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)
Cumulative Opioid consumption in the first 24 hours.	Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)	1 hour post-operative
Cumulative Opioid consumption in the first 24 hours.	Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)	4 hours post-operative
Cumulative Opioid consumption in the first 24 hours.	Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)	8 hours post-operative
Cumulative Opioid consumption in the first 24 hours.	Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)	24 hours post-operative
Post-operative pain intensity	pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain	pain at 0 hour, 0 time is considered time to admission to post anesthesia care unit
Post-operative pain intensity	pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain	pain at 1 hour post operative
Post-operative pain intensity	pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain	pain at 4 hours post operative
Post-operative pain intensity	pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain	pain at 8 hours post operative
Post-operative pain intensity	pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain	pain at 24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to patient mobilization	Recording first time patient is able to mobilize without assistance	First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit)

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Ahmed Thallaj, King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2019
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: July 7, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 29, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: E-19-3943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No